OPME: the impact of these materials on hospital costs

OPME is the Brazilian acronym for orthoses, prostheses and special materials, a group of medical devices used to replace, assist or supplement functions of the human body in surgical and therapeutic procedures. These items combine high unit value, strict traceability requirements and a high risk of denial. That is why OPME management is as much a clinical issue as a financial one for the hospital.

In orthopedic, cardiovascular and neurosurgical procedures, OPME often accounts for the largest share of the amount billed. Inadequate control of these materials, from authorization to entry on the claim, is one of the main sources of denials in hospital billing.

What orthoses, prostheses and special materials are

Normative Resolution No. 465/2021 of the ANS (Brazil’s National Supplementary Health Agency), the current rule governing OPME coverage in private healthcare, defines the three components of the acronym precisely.

An orthosis is any permanent or temporary material that assists the functions of a limb, organ or tissue. It is not tied to the surgical act when its placement or removal does not require a surgical procedure, such as a cervical collar or a foot orthosis. When surgery is required to place or remove it, health plans must cover it.

A prosthesis is any permanent or temporary material that fully or partially replaces a limb, organ or tissue. Joint prostheses, heart valves and orthopedic implants are typical examples. Health plans must cover it when placement requires a surgical procedure.

Special materials are the components and accessories needed for orthoses and prostheses to work or be implanted, such as screws, restricted-use absorbable sutures and fixation systems. Coverage is mandatory when they are tied to procedures on the ANS list and registered with Anvisa.

The impact of OPME on hospital costs

The financial impact of OPME on the hospital budget has three dimensions. The first is the acquisition cost: high-tech materials with a high unit value, subject to market fluctuations and negotiations with suppliers. The second is the management cost: logistics, inventory control, traceability and regulatory compliance. The third is the cost of risk: denials for incomplete documentation, missing authorization or traceability not formally recorded, which turn the material into a permanent loss when they are not reversed on appeal.

In high-complexity surgeries, the value of OPME materials often exceeds that of physician fees and operating room fees. A claim for advanced arthroscopy, cardiovascular surgery or spine surgery can have 60% to 80% of its value concentrated in materials. For a detailed look at the audit process for these claims, see High-cost claim audits: critical points.

Traceability: the requirement that cannot be missing

Anvisa RDC No. 14/2011 requires every implantable material to come with traceability labels, with one copy mandatorily attached to the clinical record, one for the tax documentation and one for the document given to the patient. The Ministry of Health’s Manual of Good Practices for OPME Management reinforces that the professional in charge of the procedure must record complete information on each material used in the surgical description, the operating room consumption record and the medical record: name, manufacturer, size, quantity and description of the implant.

A missing traceability label in the medical record is direct grounds for denying the material, regardless of whether it was actually implanted and whether the invoice is present. Health plans systematically check OPME traceability in high-cost claim audits.

Prior authorization and contractual compliance

Every OPME material that will be billed on the claim must be backed by the payer’s prior authorization. This means the hospital must request authorization before the procedure, indicating the specific material that will be used, with its code and technical specification.

When a material is substituted during surgery, whether because of unavailability or a clinical decision, the change must be reported to the payer and, whenever possible, a new authorization must be issued before billing. A material billed that differs from the one authorized is denied on formal grounds, even if it is clinically equivalent to what was authorized.

Compatibility between the material billed and the material authorized should be checked when the claim is closed, cross-checking the surgical description against the items entered and the scope of the authorization issued. This check is part of the prospective audit process before submission.

OPME and denial risk: what to control

OPME denials concentrate on four recurring points: a traceability label missing from the medical record, a material billed that differs from the one authorized, an invoice not linked to the item or a quantity billed that differs from the quantity used and recorded.

Each of these points has an owner in the hospital process. Traceability is the responsibility of the surgical team at the time of implantation. Authorization is the responsibility of the billing department before the procedure. The invoice is the responsibility of the storeroom or the materials center. Correct entry is the responsibility of whoever closes the claim.

When these four processes work in an integrated way, the OPME denial rate falls consistently. When any of them works in isolation, errors pile up and reach billing already consolidated, hard to correct before submission.

OPME in hospital management: from operational control to financial results

OPME control is not just a matter of claims auditing. It is a matter of integrated clinical governance and financial management. Technology makes it possible to automate much of this control: automatically cross-checking authorized materials against billed materials, verifying that traceability labels are present in the medical record and flagging discrepancies before the claim is closed.

Rivio automatically audits claims involving OPME before they are submitted to the payer, checking traceability, compliance with the authorization and invoice linkage, with billing specialists supervising every stage of the process. By contract, Rivio commits to reimbursing the hospital 100% if the denial is not reversed.

Frequently asked questions about hospital OPME

What is OPME?

OPME is the Brazilian acronym for Orthoses, Prostheses and Special Materials, medical devices used to replace, assist or supplement functions of the human body in surgical procedures. ANS Normative Resolution No. 465/2021 regulates OPME coverage in private healthcare, establishing that materials requiring surgery for placement or removal must be covered.

Why does OPME generate so many denials?

Because it combines high unit value with specific documentation requirements: a traceability label in the medical record, compliance with the prior authorization, an invoice linked to the item and an entry in the surgical description. The absence of any of these elements is sufficient grounds for a denial, regardless of whether the material was actually implanted.

What is OPME traceability?

It is the identification and recording of each implantable material throughout the surgical process, as required by Anvisa RDC No. 14/2011. Each material must have a label with information on the product, manufacturer and lot, with one copy mandatorily attached to the clinical record. Without this label in the medical record, the material can be denied even if the invoice is present.

Can the hospital bill for OPME substituted during surgery?

Yes, but it must report the substitution to the payer and, when possible, obtain a new authorization for the substitute material before billing. A material billed that differs from the one authorized, without the corresponding notice and authorization, is denied on formal grounds.